GAMMACELL 3000 ELAN— 510(k) K952291

Name: FDA 510(k) clearance K952291
Creator: U.S. Food and Drug Administration
Published: 1995-08-25

Substantially Equivalent

Nordion International, Inc.

FDA 510(k) clearance K952291 for GAMMACELL 3000 ELAN, Substantially Equivalent on 1995-08-25. Applicant: Nordion International, Inc.. Device class: Unclassified.

Clearance details

Applicant: Nordion International, Inc.
Product code: Code MOT
Device class: Unclassified
Advisory panel: Unknown
Date received: 1995-05-16
Decision date: 1995-08-25
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Washington, DC, US

Download summary PDF View on FDA.gov ↗

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